MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE; IMPLANTABLE LEAD

Model Number 0184

Device Problems High impedance (1291); Over-Sensing (1438); Pocket Stimulation (1463); Low impedance (2285); Ambient Noise Problem (2877); Device Sensing Problem (2917)

Patient Problems Muscle Stimulation (1412); No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.This report will be updated should further information be received.

Event Description

Boston scientific received information that this device and right ventricular (rv) lead exhibited high out-of-range shock impedance measurements and noise oversensing.Additionally, the measured r-wave amplitude was low.Boston scientific technical services (ts) was contacted and discussed troubleshooting steps.This lead remains in service.No adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Additional information received indicates the clinic plans to continue routine follow-up appointments with no plan for intervention.There have been no adverse patient effects.This product remains in service.

Event Description

Additional information received indicated that the patient presented to the emergency room after experiencing an uncomfortable feeling in the pocket area.The device was interrogated and was found to be in safety mode.There were also less than 200 ohm pacing impedance measurements with the rv lead.A revision procedure was performed and the device was explanted and replaced.The rv lead was surgically abandoned and a new rv lead was implanted.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5795682
• MDR Text Key: 49622530
• Report Number: 2124215-2016-11113
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/03/2010
• Device Model Number: 0184
• Other Device ID Number: ENDOTAK RELIANCE G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided; 04/12/2017
• Supplement Dates FDA Received: 10/14/2016; 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 40 YR